Back to resultsTolerability/PoP Study in Allergic Rhinitis After Intranasal Administration of AZD8848
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
AZD8848
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis focused on measuring patients, allergic rhinitis, tolerability, safety, nasal symptoms
Eligibility Criteria
Inclusion Criteria:
- Patients with a history of birch and/ or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years (verified by a positive skin prick test)
- Patients with need of treatment for their nasal symptoms during the pollen season
Exclusion Criteria:
- Clinical relevant disease or abnormality (past or present) - other than allergic rhinitis
- Symptomatic perennial allergic or non-allergic rhinitis
- A history of asthma
Sites / Locations
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Incidence/nature of adverse events,pulse, BP, body temperature, ECG parameters, lab assessments
Nasal symptoms, peak nasal inspiratory flow
Secondary Outcome Measures
Reflective Total Nasal Symptom Score, Peak Nasal Inspiratory Flow
Blood biomarkers and nasal lavage biomarkers
Pharmacokinetics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00770003
Brief Title
Tolerability/PoP Study in Allergic Rhinitis After Intranasal Administration of AZD8848
Official Title
A Double-blind, Placebo Controlled, Randomized, Parallel Group Study to Investigate the Tolerability, Safety, Pharmacodynamics and Pharmacokinetics of Repeated Weekly Doses of AZD8848 Administered Intranasally to Seasonal Allergic Rhinitis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose is to investigate tolerability/safety of repeated weekly doses of AZD8848 administered intranasally to seasonal allergic rhinitis patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
patients, allergic rhinitis, tolerability, safety, nasal symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AZD8848
Intervention Description
nasal spray solution; 30 or 60 µg administered intranasally once weekly for one month
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
nasal spray solution. Once weekly intranasal administrations for one month.
Primary Outcome Measure Information:
Title
Incidence/nature of adverse events,pulse, BP, body temperature, ECG parameters, lab assessments
Time Frame
During the study
Title
Nasal symptoms, peak nasal inspiratory flow
Time Frame
During the study
Secondary Outcome Measure Information:
Title
Reflective Total Nasal Symptom Score, Peak Nasal Inspiratory Flow
Time Frame
During the study
Title
Blood biomarkers and nasal lavage biomarkers
Time Frame
During the study
Title
Pharmacokinetics
Time Frame
During the study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a history of birch and/ or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years (verified by a positive skin prick test)
Patients with need of treatment for their nasal symptoms during the pollen season
Exclusion Criteria:
Clinical relevant disease or abnormality (past or present) - other than allergic rhinitis
Symptomatic perennial allergic or non-allergic rhinitis
A history of asthma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lennart Greiff, MD PhD
Organizational Affiliation
Lund University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leif T Eriksson, MD, PhD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Helsingborg
Country
Sweden
Facility Name
Research Site
City
Lund
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
26342289
Citation
Greiff L, Ahlstrom-Emanuelsson C, Alenas M, Almqvist G, Andersson M, Cervin A, Dolata J, Lindgren S, Martensson A, Young B, Widegren H. Biological effects and clinical efficacy of a topical Toll-like receptor 7 agonist in seasonal allergic rhinitis: a parallel group controlled phase IIa study. Inflamm Res. 2015 Nov;64(11):903-15. doi: 10.1007/s00011-015-0873-2. Epub 2015 Sep 5.
Results Reference
derived
PubMed Identifier
22726593
Citation
Greiff L, Cervin A, Ahlstrom-Emanuelsson C, Almqvist G, Andersson M, Dolata J, Eriksson L, Hogestatt E, Kallen A, Norlen P, Sjolin IL, Widegren H. Repeated intranasal TLR7 stimulation reduces allergen responsiveness in allergic rhinitis. Respir Res. 2012 Jun 22;13(1):53. doi: 10.1186/1465-9921-13-53.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1657&filename=D0540C00003_Study_Synopsis.pdf
Description
CSR Synopsis
Learn more about this trial
Tolerability/PoP Study in Allergic Rhinitis After Intranasal Administration of AZD8848
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